Aclovate (Alclometasone Dipropionate) - Indications and Dosage

INDICATIONS AND USAGE

  ACLOVATE^® Cream and Ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ACLOVATE^® Cream and Ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use). Since the safety and efficacy of ACLOVATE^® Cream and Ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.

DOSAGE AND ADMINISTRATION

Apply a thin film of ACLOVATE^® Cream or Ointment to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears.

ACLOVATE^® Cream and Ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of ACLOVATE^® Cream or Ointment in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

ACLOVATE^® Cream or Ointment should not be used with occlusive dressings unless directed by a physician. ACLOVATE^® Cream or Ointment should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.

Geriatric Use

In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with ACLOVATE^® Cream or Ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

HOW SUPPLIED

ACLOVATE^® Cream, 0.05% is supplied in:

•  15-g tubes (NDC 0173-0401-00),
•  45-g tubes (NDC 0173-0401-01), and
•  60-g tubes (NDC 0173-0401-06).

ACLOVATE^® Ointment, 0.05% is supplied in:

•  15-g tubes (NDC 0173-0402-00),
•  45-g tubes (NDC 0173-0402-01), and
•  60-g tubes (NDC 0173-0402-06).

Store between 2° and 30°C (36° and 86°F).

GlaxoSmithKline Consumer Healthcare LP

Pittsburg, PA  15230

©2002, GlaxoSmithKline. All rights reserved.

August 2002       RL-1081